Intravitreal Topotecan for Prevention or Treatment of Proliferative Vitreoretinopathy in Retinal Detachment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intravitreal topotecan, Retinal detachment surgery.
- Who it may be relevant to
- Registry conditions: Retinal Detachment Rhegmatogenous, Proliferative Vitreoretinopathy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Intravitreal Topotecan for the Prevention or Treatment of Proliferative Vitreoretinopathy in Patients with Rhegmatogenous Retinal Detachment: a Prospective Matched Cohort Study
Overview
Intravitreal topotecan exhibits strong anti-inflammatory, anti-proliferative, and anti-fibrotic properties, making it a promising option for preventing and treating proliferative vitreoretinopathy in rhegmatogenous retinal detachment. Preclinical studies have demonstrated its efficacy in proliferative vitreoretinopathy models, where no adverse events have been reported for doses of 5 µg to 30 µg. This prospective, matched cohort study aims to assess the therapeutic efficacy and safety of intravitreal topotecan for preventing and treating proliferative vitreoretinopathy in rhegmatogenous retinal detachment patients.
Detailed description
Patients who provide informed consent for participation in the experimental study arm will undergo standard-of-care retinal detachment surgery with intravitreal topotecan (8 µg/0.05 mL), diluted in sterile saline and administered preoperatively within one week before surgery, as well as one week postoperatively. Matched historical control patients who received standard-of-care retinal detachment surgery without intravitreal topotecan will be eligible for study participation. Both the experimental and historical control study arms will be further divided into two groups: (i) patients with rhegmatogenous retinal detachment who exhibit high-risk characteristics of proliferative vitreoretinopathy on optical coherence tomography or have early proliferative vitreoretinopathy confirmed by clinical examination, and (ii) patients with rhegmatogenous retinal detachment who have neither high-risk characteristics of proliferative vitreoretinopathy nor a history of proliferative vitreoretinopathy.
Interventions
- Drug Intravitreal topotecan
Patients who meet all inclusion criteria and none of the exclusion criteria will receive intravitreal topotecan (8 µg in 0.05 mL). The treatment will be administered within one week before retinal detachment surgery (pneumatic retinopexy, pars plana vitrectomy, and/or scleral buckling) and one week after surgery, for a total of two injections. - Procedure Retinal detachment surgery
Standard retinal detachment surgery (pneumatic retinopexy, three-port pars plana vitrectomy, and/or scleral buckling).
Primary outcome measures
- Rate of recurrent rhegmatogenous retinal detachment secondary to proliferative vitreoretinopathy [Time frame: 6 months or last follow-up]
Secondary outcome measures (6)
- Grade of proliferative vitreoretinopathy [Time frame: 6 months or last follow-up]
- Rate of primary retinal reattachment [Time frame: 6 months or last follow-up]
- Rate of final retinal reattachment [Time frame: 6 months or last follow-up]
- Best-corrected visual acuity [Time frame: 6 months or last follow-up]
- Change in best-corrected visual acuity from baseline [Time frame: 6 months or last follow-up]
- Rate of complications [Time frame: 6 months or last follow-up]
Eligibility criteria
Inclusion criteria
- Patients aged 18 years and older
- Patients who undergo pneumatic retinopexy, pars plana vitrectomy and/or scleral buckling for rhegmatogenous retinal detachment
- Patients who are voluntarily able and willing to participate
Patients undergoing combined phacoemulsification and pars plana vitrectomy and/or scleral buckling will also be included. Any surgical technique will be considered, including relaxing retinotomy or retinectomy during pars plana vitrectomy.
Exclusion criteria
- Patients with a history of exudative retinal detachment
- Patients with severe non-proliferative or proliferative diabetic retinopathy
- Patients with other planned ocular surgery following pars plana vitrectomy
- Female patients of childbearing age (i.e. less than 50 years old) who intend to become pregnant over the course of the study
- Patients with pre-existing bone marrow suppression or cytopenias
- Patients with pre-existing interstitial lung disease
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Canada · 2 centers
- St. Michael's Hospital — Toronto
- Sunnybrook Health Sciences Centre — Toronto
Identifiers
NCT: NCT06818721 · TOPO-PT